Sandoz Group AG

Tonix Pharmaceuticals presented data on TNX-102 SL, a sublingual cyclobenzaprine HCl, at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems. The eutectic formulation of TNX-102 SL is expected to provide market exclusivity until at least 2034. The U.S. FDA New Drug Application (NDA) submission is on track for October 2024, with a 2025 PDUFA date for FDA decision. The Phase 3 RESILIENT study results showed significant improvement in fibromyalgia pain and sleep quality.

After a July surge in FDA approvals for gastroenterology, including the first blood test for colorectal cancer, the agency saw a summer lull with only three GI approvals. Notable approvals included Skyrizi for UC and Crohn’s, a rapid HCV test for point-of-care use, and a third ustekinumab biosimilar.

Generics and biosimilars saved $445 billion in 2023, totaling $3.1 trillion over 10 years, with 90% of US prescriptions and 13% of drug spending. Biosimilars alone saved $12.4 billion in 2023, totaling $36 billion since 2015, benefiting patients with conditions like heart disease, mental health, and cancer. States averaged over $8 billion in savings, with California leading at nearly $38 billion.

The global erythropoietin drugs market is projected to grow at a CAGR of 3.8% from 2024 to 2034, reaching $14.3 billion by 2034. Advances in precision medicine, regulatory reforms for biosimilars, and telemedicine integration are driving market growth. Key players include Amgen, Roche, and Johnson & Johnson. Epoetin Alfa and biosimilars lead the market segments.

United Therapeutics found liable for breaching 2015 agreement with Sandoz, resolving patent dispute; court ruled in favor of Sandoz Inc.

Regeneron accuses Sandoz of patent infringement on Eylea and BPCIA violations, alleging Sandoz withheld critical info during biosimilar approval.

Court finds United Therapeutics' interference with generic Treprostinil Injection launch caused over $137 million in losses; proceeds from litigation to be split equally between Sandoz and Liquidia PAH, with Liquidia PAH's share further divided between Henderson SPV and PBM RG Holdings.

The 'Migraine: Seven-Market Drug Forecast and Market Analysis' report, added to ResearchAndMarkets.com's offering, forecasts the migraine market in the US, France, Germany, Italy, Spain, the UK, and Japan to grow from $9.2 billion in 2023 to $16.4 billion by 2033, driven by a 6.0% CAGR. The report covers epidemiology, treatment options, unmet needs, pipeline analysis, and market competition.

The Basel Area is a leading European hub for life sciences and biotech, attracting major companies like Roche and Novartis. Its appeal lies in a rich ecosystem of research, talent, and infrastructure, making it a prime location for innovation and growth in the sector.

FDA approves Enzeevu (aflibercept-abzv), a biosimilar to Eylea, for intravitreal injection in patients with neovascular age-related macular degeneration (nAMD). Enzeevu is a key biosimilar value driver for Sandoz, extending its leading US ophthalmology portfolio. The approval is based on comprehensive analytical, preclinical, and clinical data from the Mylight study.